NCT00494780 - Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

September 30, 2010

Conditions

Lymphoma, Follicular

Interventions

DRUG

Ofatumumab

ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

DRUG

Doxorubicin

Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start

DRUG

Vincristine

Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

DRUG

Prednisolone, Prednisone or equivalent

100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Trial Locations (1)

14263

GSK Investigational Site, Buffalo